Product code SDA

Device name
Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer
Medical specialty
Unknown
Device class
3
Review panel
AN
Implant
N
Life sustaining/supporting
Y
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
Optune Lua concurrent with PD-1/PD-L1 inhibitors or docetaxel is indicated for adult patients with metastatic non-small cell lung cancer who have progressed on or after a platinum-based regimen.
Source
FDA openFDA device classification dataset